Field of the Invention
This disclosure relates, in general, to the field of medical connectors and, more particularly, to a medical connector assembly for retaining sterility of a reusable portion of the medical connector assembly.
Description of the Related Art
Typical medical connectors are provided for use with various medical devices, including dosage containers, administration sets, catheters, and medical lines. These connectors are commonly used in numerous medical procedures where it is necessary to, for example, draw a drug from a container and/or deliver medical fluid(s) to one or more patients. One example of such a connector is a rubber septum provided on a conventional drug vial and a needle for withdrawing a quantity of the drug from the drug vial. Each time the drug vial is accessed for the purpose of withdrawing a quantity of the drug therefrom, the rubber septum is typically disinfected with a disinfectant, such as alcohol. The user then pierces the rubber septum with a needle to withdraw a quantity of the drug from the drug vial. After withdrawing the needle from the rubber septum, the elastic nature of the septum material re-seals the drug vial thereby maintaining a sealed connection between the interior and exterior of the drug vial. The user may then utilize the needle to deliver the drug to the patient. In this example, the needle may be considered to be a single use connector that is used only once for each patient and then disposed of as medical waste.
Another example of a medical connector is a swabbable valve and a corresponding single use connector. In this example, the user must swab the connection valve with a disinfectant, such as alcohol, to clean the connection surface before mating the connection valve to the single use connector. The single use connector may be a luer fitting. Commonly, swabbable valves must be swabbed for at least 15 seconds with a disinfectant, after which a waiting period of at least 45 seconds is required for the disinfectant to evaporate. In practice, it is often the case that the connection valve is not disinfected for a proper length of time, if at all.
Conventional medical connectors are generally provided in pre-sterilized, sealed packages prior to use. A user, such as a medical practitioner, must remove the medical connector prior to use. While it is possible to maintain sterility in manufacturing and packaging of medical connectors, various sources of contamination may be introduced as soon as the medical connector is removed from the pre-sterilized, sealed package. For example, airborne particles, such as germs in droplets from coughs or sneezes, may accumulate on a fluid connection element of the medical connector, thereby contaminating it. Spores and dust are additional airborne particulates that may contaminate the medical connector. In use, the medical connector may be contaminated by inadvertent contact with a non-sterile material, such as the clothing or body of a medical practitioner or a patient. Sterility may be further compromised in the process of making a connection between a medical connector and a medical container by touching a non-sterile surface.
Even though various medical connectors of myriad designs have been used for many years, they are associated with a number of drawbacks. During use, it is essential that all contact with non-sterile surfaces is avoided and that exposure to airborne contaminants is reduced, minimized, or eliminated. Each time a fluid connection is established between a medical article, such as a syringe, a dosage container, or a pump, and a fluid line connected to a patient, such as connected to a catheter inserted into the patient, a new, sterile medical connector should be used to connect the fluid line between the medical article and the patient. However, sterility of connection between various medical connector components is often compromised once the medical connector is taken from a sterile environment, such as its packaging. Conventional medical connectors are often provided with dust caps to prevent inadvertent contact with non-sterile surfaces or airborne contaminants. For example, U.S. Pat. No. 2,780,243 (Williams et al.) and U.S. Pat. No. 3,987,930 (Fuson) disclose respective embodiments of stackable or nestable dust caps that are suitable for extended storage, and U.S. Pat. No. 4,778,447 (Velde et al.) discloses a medical connector with both male and female protective caps. However, these means of maintaining sterility are not always utilized in practice. Additionally, providing dust caps on each connector component increases the complexity of such articles, making them prohibitively costly in many instances due to their single use nature as well as increasing the amount of waste requiring disposal.
Various two-piece medical connectors are also known in the medical field, such as from U.S. Pat. No. 4,981,469 to Whitehouse et al. and U.S. Pat. No. 7,241,285 to Dikeman. Whitehouse et al. is directed to an assembly for connection to a medicant supply tube and includes a septum assembly including a distal end cap, a septum cap, and an external adapter. Dikeman discloses a medical connector for connecting a fluid passage device, such as may be provided by a luer taper, and an injection site having a thin diaphragm. The medical connector includes a reduced diameter cannula for engaging the thin diaphragm sufficiently to open the thin diaphragm to establish an open fluid passage. U.S. Pat. No. 6,911,025 to Miyahara is directed to a dialysis connector in which a patient side connector is enclosed by a long term use protective cap which encloses a sterile inner cap that is replaced at the conclusion of each dialysis procedure.
Each of the foregoing designs is based on single use connector that the user must replace before making a new fluid connection between a medical article and a patient. Because of their single use design, conventional medical connectors require the user to ensure that proper sterilization precautions are taken each time a new connection is required. Additionally, there exists a significant risk of contamination due to human error in placing and removing dust caps from single use connectors. Furthermore, because no parts of conventional medical connector designs are reusable, large stockpiles of medical connectors must be kept on premises, which increase storage costs and per procedure costs.
The discussion has centered upon the fluid supply side of the fluid delivery system. There are similar or even greater issues, needs, and problems on the patient receiving side where because of the physical pain or discomfort to the patient and the healthcare worker's difficulty of getting vascular access to the patient, there is often the need for sequential delivery or withdrawal of fluids from a single patient vascular access device over the time of their treatment. This is currently solved by using swabbable valves mentioned above or needleless septa. Both of these have significant problems as described above. In addition, it is desirable to have features that reduce the opportunity for blood from a patient to get into the environment.